This revised guide is intended to be used in conjunction with ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems and other ISPE GAMP® guidance documents. Item reflects changes in typical system architecture since the First Edition, and also covers Software as a Service (SaaS) and other cloud solutions.
Thank you to all guide contributors:
Winnie Cappucci, Bayer Healthcare (retired), US Chris Clark, TenTenTen Consulting, United Kingdom Gail Evans, Technical Writer/Editor, United Kingdom Colin Jones, Conformity Limited, United Kingdom David Stokes, Convalido Consulting Limited, United Kingdom Randy Perez (Lead), Novartis (retired), US Lorrie Vuolo-Schuessler, GlaxoSmithKline, US Christopher White, Alexion Pharmaceuticals, US Sion Wyn, Conformity Limited, United Kingdom